Approvals (Drugs@FDA)

IVERMECTIN

AJANTA PHARMA LTD · IVERMECTIN

ANDA218509Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218509
Sponsor name
AJANTA PHARMA LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260407
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    IVERMECTIN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      IVERMECTIN
      Strength
      3MG
Harmonized identifiers (openFDA)
Application number
ANDA218509
Brand name
IVERMECTIN
Generic name
IVERMECTIN
Manufacturer name
Ajanta Pharma USA Inc.
Product NDC
27241-293
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
IVERMECTIN
RxCUI
311207
SPL ID
3a1375c9-01f7-4ff7-8208-5a7baf4de267
SPL set ID
1fb17bc2-9192-4a0b-a3ee-fda9db035daa
Package NDC
27241-293-73
Nui
N0000175484, N0000181811
Pharm class epc
Antiparasitic [EPC], Pediculicide [EPC]
UNII
8883YP2R6D
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.